Home / 510(k) Clearances / K822870

510(k) K822870

STOOL-COLLECTION/PRESERVATION KIT by American Scientific Products — Product Code KDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1982
Date Received
September 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen Mailer And Storage, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
PA
Submission Type

Other clearances by American Scientific Products

  • K864824 — INFECTIOUS TISSUE KIT (December 24, 1986)
  • K844042 — BLOOD DILUTION VIAL (October 23, 1984)
  • K831634 — GLUCOSE REAGENT B6360-11 (July 19, 1983)
  • K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A (July 7, 1983)
  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K831571 — ROTOR (June 30, 1983)

Other clearances for product code KDT

  • K873593 — BIOSURE SPECIMEN COLLECTION CONTAINER (November 25, 1987)
  • K862665 — NOVACYTE-U (September 4, 1986)
  • K834579 — BIOSPAL 2400S (February 4, 1984)
  • K834412 — PRESERV PVA FIXATIVE 15ML-FORMALIN PK (January 13, 1984)
  • K833660 — PRESERV PVA FIXATIVE -MALIN PACK (November 28, 1983)
  • K823773 — PROVIAL II #006-010-0201 (January 21, 1983)
  • K821621 — PREGNOPOST (July 21, 1982)
  • K820246 — PREFILLED SPECIMEN CONTAINER (February 18, 1982)
  • K811793 — FIX-RIGHT 90ML & 180 ML PREFILLED CONT (July 31, 1981)
  • K800946 — URINARY CATHETER SAMPLING KIT (June 20, 1980)